bon E-20 SE, Инструкция по эксплуатации

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2 Important information
bon E-20 SE
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2 Important information
Manufacturer: bon Optic Vertriebsgesellschaft mbH · Stellmacherstr. 14 · D- 23556 Lübeck
2.1 Information about the device
Device description: bon E-20 SE
2.2 Intended purpose and classification
The bon E-20 SE refraction unit is used in conjunction with ophthalmological instruments
such as slitlamps and opthalmometers. During use in an ophthalmic examination these
devices are positioned in front of the patient.
According to the classification rules of the Medical Device Directive 93/42/EWG, the bon
E-20 SE refraction unit is classified as a non invasive medical active product class 1.
2.3 Liability
The Refraction Unit is manufactured according to the recognized technical safety regulations
and is tested to the strictest quality measures. The company bon Optic accepts responsibility
for the safety, reliability and performance of the device only when:
ƒ
Mounting, modification and commissioning are carried out by a person(s) authorised
to do so by bon Optic.
ƒ
The power supply to which the device is connected corresponds to the national
legislation.
ƒ
The device is only used in accordance with this instruction manual.
ƒ
The user operates in accordance with the Medical Device Use Practice (MPBetreibV).
The manufacturer will not accept liability should the system be assembled, amended or
commissioned by an unauthorised person, should it be improperly serviced, or should it be
other than as described under 2.2 .